GUARDRX RED THYME- hand sanitizer liquid GUARDRX LAVENDER PEPPERMINT- hand sanitizer liquid GUARDRX UNSCENTED- hand sanitizer liquid

GuardRx Unscented by

Drug Labeling and Warnings

GuardRx Unscented by is a Otc medication manufactured, distributed, or labeled by GPS Associates, GPS Associates, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Ethanol 62%

Purpose:

Uses:

-For hand washing to decrease bacteria on skin.

-Recommended for repeated use.

WARNINGS:

-Flammable, keep away from children.

-For external use only.

-Do not use in eyes. If contact occurs, flush thoroughly with water.

-Stop use and ask a doctor if redness and irritation develop and persist for more than 72 hours.

-Keep our of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

Directions:

Wet hands thoroughly with product and allow to dry without wiping.

-Do not use other than directed.

STORAGE AND HANDLING

Store at room temperature 20-25 °C (66-77 °F)

Inactive Ingredients:

Aqua, Glycerin, Citrus Aurantium Dulcis (Orange) Peel Oil, Thymus Vulgaris (Red Thyme) Oil, Tocopherol.

Active Ingredients:

Ethanol 62%

Purpose:

Antiseptic

Uses:

-For hand washing to decrease bacteria on skin.

-Recommended for repeated use.

WARNINGS:

-Flammable, keep away from children.

-For external use only.

-Do not use in eyes. If contact occurs, flush thoroughly with water.

-Stop use and ask a doctor if redness and irritation develop and persist for more than 72 hours.

-Keep our of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

Directions:

Wet hands thoroughly with product and allow to dry without wiping.

-Do not use other than directed.

STORAGE AND HANDLING

Store at room temperature 20-25 °C (66-77 °F)

Inactive Ingredients:

Aqua, Glycerin, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Tocopherol.

Active Ingredients:

Ethanol 62%

Purpose:

Antiseptic

Uses:

-For hand washing to decrease bacteria on skin.

-Recommended for repeated use.

WARNINGS:

-Flammable, keep away from children.

-For external use only.

-Do not use in eyes. If contact occurs, flush thoroughly with water.

-Stop use and ask a doctor if redness and irritation develop and persist for more than 72 hours.

-Keep our of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

Directions:

Wet hands thoroughly with product and allow to dry without wiping.

-Do not use other than directed.

STORAGE AND HANDLING

Store at room temperature 20-25 °C (66-77 °F)

Inactive Ingredients:

Aqua, Glycerin, Tocopherol.

59 mL NDC:

74306-123-02

118 mL NDC:

74306-123-04

236 mL NDC:

74306-123-08

59 mL NDC:

74306-124-02

118 mL NDC:

74306-124-04

236 mL NDC:

74306-124-08

59 mL NDC:

74306-125-02

118 mL NDC:

74306-125-04

236 mL NDC:

74306-125-08

INGREDIENTS AND APPEARANCE

GUARDRX RED THYME 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74306-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ORANGE OIL (UNII: AKN3KSD11B)
WATER (UNII: 059QF0KO0R)
THYME OIL (UNII: 2UK410MY6B)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74306-123-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/31/2020
2	NDC: 74306-123-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/31/2020
3	NDC: 74306-123-08	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/31/2020

GUARDRX LAVENDER PEPPERMINT 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74306-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74306-124-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/31/2020
2	NDC: 74306-124-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/31/2020
3	NDC: 74306-124-08	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/31/2020

GUARDRX UNSCENTED 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74306-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74306-125-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/31/2020
2	NDC: 74306-125-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/31/2020
3	NDC: 74306-125-08	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/31/2020

Labeler - GPS Associates (096942063)

Registrant - GPS Associates, LLC (096942063)

Establishment
Name	Address	ID/FEI	Business Operations
GPS Associates		096942063	manufacture(74306-123, 74306-124, 74306-125)